(a) Field of the Invention
The present invention relates to containers for the accounting and disposing of expendable medical items, including operating room sharps, such as, for example, suture needles and scalpel blades.
Accounting for operating room sharps is a safety measure, designed to decrease the risk of patient injury. Without an accurate sharps accounting system, the risk of inadvertently leaving and overlooking a suture needle or scalpel blade in a patient's body is believed to be significantly increased. The number of used sharps accounted for at the completion of the procedure should equal the number of sharps introduced during the procedure. By disposing of each sharp individually in an apparatus which accurately counts the sharps and places them in a secure receptacle, if the count on the disposal apparatus at the completion of a procedure matches the sharps used, then one can conclude with a high degree of confidence that all sharps have been accounted for and the risk of patient injury due to a misplaced sharp is minimized.
The safe disposal of used operating room sharps is also important. Since sharps are normally used to penetrate or cut human tissue, there is a possibility that used sharps have been contaminated with infectious material. Throughout the disposal process, the user should be sufficiently protected against sharp or needle sticks.
(b) Description or Prior Art
The current method of counting and disposing of used operating room sharps relies on a small open plastic "box" or container that incorporates a visual aid, usually sequential numbers printed in a matrix on the base of the box. The base is often contains a block of flexible foam material or a magnetic sheet. The foam block and/or magnetic sheet serve as a means to secure the used sharps in the plastic container. During surgical procedures, once a sharp is used, it is sequentially secured in the plastic container in a numbered slot. To secure the sharp, the sharp is forced into the foam block or strip, or laid on the magnetic sheet. Any remaining suture material is cut from the needle either before or after the sharp is secured in the box. At the end of the surgical procedure, the sequentially secured used sharps are counted and the results are verified against a predetermined count. If the actual ending count matches the predetermined count, then, the likelihood of a sharp being inadvertently left in the patient's body is minimized.
There are significant problems associated with the current counting system. First, the difficulty in securing the sharp into a numbered slot within the confines of a small container presents handling problems for the user. These handling problems introduce a potential safety hazard because the sharps may be contaminated. Further, they reduce operating room efficiency. Second, the accuracy of the count is prone to human errors. Often, by the end of the procedure, there can be as many as 120 different sized sharps contained in one small needle counter. This high concentration of sharps makes it very difficult to visually ensure an accurate count. Third, due to the variance in the number and type of surgical procedures being performed in any given institution, the purchasing and storing of different styles of needle counters results in potential inventory problems. Fourth, since the current needle counters encompass a variety of materials and processes, environmental disposal issues are raised.
The known prior art teaches disposal systems having rotatable trays, hinged lids, pivoting chutes, and the like. No prior art is known teaching a sharps disposal apparatus having a drop window with a safety shutter, an automatic counter, or a pinch cutter.
U.S. Pat. No. 5,076,429 teaches a sharps container 10 having a bucket 12, lid 14, and tray 16. Tray 16 receives sharps and is rotated by flats or handle 22 to place them into bucket 12. Baffle flap 40 seals the container.
U.S. Pat. No. 5,046,614 teaches a needle and sharps disposal container 10 having a hollow container body 12 and top 14. Top 14 has partial stationary cylinder 22 with surfaces 18 and 20 and slot 34 to receive needles and sharps for disposal; rotatable cylinder 22 being contained in stationary cylinder 24.
U.S. Pat. No. 4,903,390 teaches a scalpel blade removal apparatus 40 for removing blades 14 from scalpel handle 12 and retaining blades 14 in housing 42.
U.S. Pat. No. 4,890,733 teaches a disposal receptacle for used sharps, etc. Receptacle 10 comprises a bucket 14 with cover 18. Cover 18 has chute 32. Pivotally mounted scoop 50 receives items to be disposed.
U.S. Pat. No. 4,842,138 teaches a container 10 comprising a bottom part 20, a top part 30, a sliding cover 60, and a pair of cover rails 70A and 70B. Rectangular barrier flap 50 swings inwardly into container 10 when items are inserted. In addition to large opening 44, smaller opening 46 is included for receiving smaller, more specific items, such as "Luer" and "Vacutainer"-type hypodermic needles.
U.S. Pat. No. 4,828,107 teaches a disposable container 10 for syringes: container 10 having body 12, cover 14, and dome 16. Lever 20 and dump tray 18 are used to place items into body 12.
U.S. Pat. No. 4,736,844 teaches a sharps disposal container 1 with compartments 2 and 3. Lid 4 closes compartment 3. Compartment 2 has slot 13 to receive scalpel blades 21. Needles from sutures 22 and hypodermic syringes 23 are inserted into dense foam strips of compartment 3. Smaller items are stuck to adhesive layer 9. Items can be manually counted and container 1 then incinerated.
U.S. Pat. No. 4,715,498 teaches a sharps disposal system 10 having outer enclosure 12 and inner container 14. Outer enclosure 12 has opening 34 defined by shelf 32 and cowl 28. Tab 70 is moved to open closure 48 to receive items for disposal.
U.S. Pat. No. 4,714,168 teaches a container having a lower body 2 and upper body 4. Handle 30, wall 24, and lid 16 are pivoted together so that items to be disposed can be inserted.
U.S. Pat. No. 4,418,821 teaches using foam blocks 11 with numbers 12 to manually receive needles 14 and magnetic strip 13 to receive surgical blades 15.